Clinical-pathological Characterization and Outcomes of Metastatic Urothelial Cancer in Latin America

Completed

• Conditions: Recurrent/Metastatic Urothelial Cancers

• Registration Number: NCT03942497
• Lead Sponsor: Latin American Cooperative Oncology Group

Brief Summary

The LACOG 1518 study will characterize demographic and clinical-pathological profile of patients diagnosed with recurrent/ metastatic urothelial cancer in Latin America.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-05-06
• Study First Posted: 2019-05-08
• Study Start: 2019-08-01
• Primary Completion: 2021-08-31
• Study Completion: 2022-02-28
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

1. Age at least 18 years;
2. Histological confirmation of urothelial carcinoma (include mixed urothelial histology);
3. Diagnosis of recurrent or metastatic (Stage IV) urothelial carcinoma during the period of January 2016 to July 2018;
4. Site and investigator ability to collect adequate patient characteristics, treatment and outcome data from medical records;
5. Availability of tumor sample (FFPE/slides) from primary tumor or metastatic site at the time of registration.

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Exclusion Criteria

1. Synchronous tumors or history of other malignancy in the previous 3 years before study entry (exception to non-melanoma skin cancer or non-invasive cancers);
2. Pure non-urothelial carcinoma histology.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiology	2 years	Overall survival (OS) will be defined from the date of treatment initiation to date of death from any cause. In case of patients that received palliative care only, OS will be defined from date of diagnosis of advanced disease to date of death from any cause. Patients who are alive will be censored at the date of last known contact.

Secondary Outcome Measures

Name	Time	Method
Socioeconomic chactacteristcs	2 years	Health Care Insurance (Public or Private)
Overall response	2 years	Defined as the proportion of patients who have a partial or complete response to therapy according to RECIST 1.1
PFS	2 years	Progression-free survival (PFS) will be defined from date of treatment initiation to date of disease progression or death from any cause, whichever occurs first in each line.
Duration of response	2 years	Defined as the time from response to progression by RECIST v11.1 or death

Trial Locations

Locations (9)

CPO Pucrs; 🇧🇷 Porto Alegre, RS, Brazil

CEPON; 🇧🇷 Florianópolis, SC, Brazil

Centro Paulista de Oncologia; 🇧🇷 São Paulo, SP, Brazil

Clínica AMO; 🇧🇷 Salvador, BA, Brazil

Hospital São Rafael; 🇧🇷 Salvador, BA, Brazil

CLION; 🇧🇷 Salvador, BA, Brazil

LIGA; 🇧🇷 Curitiba, PR, Brazil

Sírio Libanês; 🇧🇷 São Paulo, SP, Brazil

Beneficência Portuguesa; 🇧🇷 São Paulo, SP, Brazil